A Kitajima, K Maekawa, K Yoshii, H Komatsu, T Tanimoto
{"title":"[国家卫生科学研究所醋酸泼尼松龙参比标准(Control 941)]。","authors":"A Kitajima, K Maekawa, K Yoshii, H Komatsu, T Tanimoto","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>The raw material for prednisolone acetate was tested for preparation of the \"Prednisolone Acetate Reference Standard (Control 941)\". Analytical data obtained were as follows: melting point, 237.5 degrees C (decomposition); UV and infrared spectra, the same as those for JP Prednisolone Acetate Reference Standard (Control 903), respectively; specific absorbance at lambda max E1%1cm = 379; optical rotation, [alpha]20D = +115.2 degrees; thin-layer chromatography and high-performance liquid chromatography (HPLC), no impurities were detected, respectively; assay, 100.8% by HPLC. Based on the above results, the candidate material was authorized as the Japanese Pharmacopoeia Reference Standard (Control 941).</p>","PeriodicalId":11656,"journal":{"name":"Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences","volume":" 113","pages":"107-10"},"PeriodicalIF":0.0000,"publicationDate":"1995-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Prednisolone acetate reference standard (Control 941) of the National Institute of Health Sciences].\",\"authors\":\"A Kitajima, K Maekawa, K Yoshii, H Komatsu, T Tanimoto\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The raw material for prednisolone acetate was tested for preparation of the \\\"Prednisolone Acetate Reference Standard (Control 941)\\\". Analytical data obtained were as follows: melting point, 237.5 degrees C (decomposition); UV and infrared spectra, the same as those for JP Prednisolone Acetate Reference Standard (Control 903), respectively; specific absorbance at lambda max E1%1cm = 379; optical rotation, [alpha]20D = +115.2 degrees; thin-layer chromatography and high-performance liquid chromatography (HPLC), no impurities were detected, respectively; assay, 100.8% by HPLC. Based on the above results, the candidate material was authorized as the Japanese Pharmacopoeia Reference Standard (Control 941).</p>\",\"PeriodicalId\":11656,\"journal\":{\"name\":\"Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences\",\"volume\":\" 113\",\"pages\":\"107-10\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"1995-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
[Prednisolone acetate reference standard (Control 941) of the National Institute of Health Sciences].
The raw material for prednisolone acetate was tested for preparation of the "Prednisolone Acetate Reference Standard (Control 941)". Analytical data obtained were as follows: melting point, 237.5 degrees C (decomposition); UV and infrared spectra, the same as those for JP Prednisolone Acetate Reference Standard (Control 903), respectively; specific absorbance at lambda max E1%1cm = 379; optical rotation, [alpha]20D = +115.2 degrees; thin-layer chromatography and high-performance liquid chromatography (HPLC), no impurities were detected, respectively; assay, 100.8% by HPLC. Based on the above results, the candidate material was authorized as the Japanese Pharmacopoeia Reference Standard (Control 941).